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系统评价治疗多发性硬化症获批疗法与 SARS-CoV-2 感染风险和 COVID-19 严重程度的关系。

Systematic review of risk of SARS-CoV-2 infection and severity of COVID-19 with therapies approved to treat multiple sclerosis.

机构信息

Division of Epidemiology I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Room 2481, Silver Spring, MD, 20993-0002, USA.

出版信息

Neurol Sci. 2022 Mar;43(3):1557-1567. doi: 10.1007/s10072-021-05846-3. Epub 2022 Jan 10.

Abstract

There is growing concern that multiple sclerosis (MS) patients on certain therapies may be at higher risk for severe coronavirus disease 2019 (COVID-19). We conducted a systematic literature review to examine the available data on U.S. therapies approved to treat MS and the risk of SARS-CoV-2 infection or severe COVID-19 outcomes. We conducted searches in PubMed, Embase, and the WHO COVID-19 database through May 2, 2021, and retrieved articles describing clinical data on therapies approved to treat MS and the risk of infection with SARS-CoV-2 or the effects of such therapies on clinical outcomes of COVID-19. The literature search identified a total of 411 articles: 97 in PubMed, 227 in Embase, and 87 in the WHO database. After excluding duplicates and screening, we identified 15 articles of interest. We identified an additional article through a broader secondary weekly search in PubMed. Thus, ultimately, we reviewed 16 observational studies. Available data, which suggest that MS patients treated with anti-CD20 monoclonal antibodies may be at increased risk for severe COVID-19, are subject to relevant limitations. Generally, studies did not identify increased risk for COVID-19 worsening with other therapies approved to treat MS. Based on observational data, biological plausibility, novelty of the drug-event association, and public health implications in a subpopulation with potential impaired response to the COVID-19 vaccines, this safety signal merits further monitoring.

摘要

人们越来越担心,某些疗法下的多发性硬化症 (MS) 患者可能面临更高的严重 2019 年冠状病毒病 (COVID-19) 风险。我们进行了系统的文献回顾,以检查美国批准用于治疗 MS 的疗法的现有数据,以及 SARS-CoV-2 感染或严重 COVID-19 结果的风险。我们通过 2021 年 5 月 2 日的 PubMed、Embase 和世界卫生组织 COVID-19 数据库进行了检索,并检索了描述批准用于治疗 MS 的疗法的临床数据,以及 SARS-CoV-2 感染风险或此类疗法对 COVID-19 临床结果的影响的文章。文献检索共确定了 411 篇文章:97 篇在 PubMed 中,227 篇在 Embase 中,87 篇在世界卫生组织数据库中。在排除重复项并进行筛选后,我们确定了 15 篇相关文章。我们通过在 PubMed 中进行更广泛的每周二次检索发现了另外一篇文章。因此,最终我们共审查了 16 项观察性研究。现有数据表明,接受抗 CD20 单克隆抗体治疗的 MS 患者可能面临更高的严重 COVID-19 风险,但存在相关局限性。通常,研究并未发现其他批准用于治疗 MS 的疗法与 COVID-19 恶化风险增加相关。基于观察性数据、药物事件关联的生物学合理性、药物的新颖性,以及在对 COVID-19 疫苗潜在反应受损的亚人群中的公共卫生意义,该安全性信号值得进一步监测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0fe/8743352/ea90518c65eb/10072_2021_5846_Fig1_HTML.jpg

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